Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT03906604
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of bilateral CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months
* Willingness to undergo bilateral carpal tunnel surgical treatment with one side having the TCTR and the other a mini open carpal tunnel release
* Age 18-65 years of age
* Clinical examination findings (compression test, Tinels, Phalens, etc) consistent with carpal tunnel syndrome.
* Persistence of symptoms after 6 weeks of conservative treatment such as splinting, activity modification, and/or injection therapy.
* Electromyographic evidence of mild, moderate, moderately severe, or severe median nerve neuropathy at the wrist
* Able and willing to complete all follow-up appointments
Exclusion Criteria:
* Previous CTS surgical release on any of their hands
* Diabetes mellitus
* Hypothyroidism
* Significant Hand arthritis (rheumatologic or osteoarthritis)
* Pregnancy
* Electromyographic evidence of any condition other than CTS affecting the hand
* Workman's compensation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03906604
Study Brief:
Protocol Section:
NCT03906604